Medical device manufacturer, Shenzhen Mindray Bio-medical Electronics Co Ltd, has issued a field safety notice concerning WATO EX-55 and WATO EX-65.
In April 2012, Mindray WATO EX-55 and WATO EX-65 Anesthesia Machines have been identified to have pneumatic circuit short connection issue and vaporizer manifold is slipped from pneumatic circuit. According to the manufacturer, the short connection may cause supply failure of the anesthesia agents which patient may become awake during operation. So far, only one clinical case had occurred in the Mainland China involving WATO EX-65 which the doctor applied proper methods to complete the operation. The root cause of the problem was identified to be due to one employee in the Mainland China who did not follow the production process during the assembly.
The manufacturer will recall and repair all the affected devices.
According to the local supplier, the affected products were not distributed in Hong Kong. If you are in possession of the products, please contact your supplier for necessary actions.
Posted on 27 September 2012